Flow obstruction treatment method

ABSTRACT

Disclosed is an apparatus and method for the treatment of the symptoms of obstructive prostatism. The apparatus comprises an expandable dilation catheter and preferably an axially elongate sheath, adapted for transurethral insertion via the external opening of the urethra. The sheath is ellipsoid in cross-section, and provides an initial path through which the catheter and a standard cystoscope lens is guided. The dilation catheter or the sheath are provided with a non-radiological locating means for positioning the dilation portion of the catheter with respect to an anatomical landmark. Once the catheter has been properly positioned with respect to both the bladder neck and the sphincter, the dilation balloon may be inflated to force open the affected prostatic urethra and eliminate the obstruction.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 08/114,200,filed Aug. 30, 1993, which is a continuation of application Ser. No.07/722,899, filed Jun. 28, 1991, U.S. Pat. No. 5,312,430, which is acontinuation of application Ser. No. 07/360,088, filed Jun. 1, 1989, nowU.S. Pat. No. 5,030,227, which was a continuation-in-part of applicationSer. No. 07/201,686, filed Jun. 2, 1988, now U.S. Pat. No. 5,007,898.Application Ser. No. 07/722,899 is also a continuation-in-part ofapplication Ser. No. 07/535,999, filed Jun. 8, 1990, now abandoned,which was a continuation of application Ser. No. 07/427,924, filed Oct.25, 1989, now abandoned, which was a continuation of application Ser.No. 07/229,155, filed Aug. 5, 1988, now abandoned, which was acontinuation of application Ser. No. 06/939,754, filed Dec. 9, 1986, nowU.S. Pat. No. 4,762,128.

BACKGROUND OF THE INVENTION

The present invention relates generally to the field of catheters. Morespecifically, the present invention relates to catheters which areadapted to be inserted into the urethral lumen to alleviate obstructiveprostatism, a condition quite common in males over the age of 50.

The prostate is a somewhat pear-shaped gland that extends around theurethral lumen from the neck of the bladder to the pelvic floor. Becauseof the close relationship of the prostate to the urethra, enlargement ofthe prostate, usually referred to as hypertrophy or hyperplasia, mayfairly quickly obstruct the urethra, particularly if the hyperplasiaoccurs close to the lumen. Such an obstruction inhibits normalmicturition, which causes an accumulation of urine in the bladder.

The surgical treatment of hyperplasia of the prostate gland has been aroutine procedure in the operating room for many years. One method ofsurgical treatment is open prostatectomy whereby an incision is made toexpose the enlarged prostate gland and remove the hypertrophied tissueunder direct vision. Another method of treating obstructive prostatismis a technique known as transurethral resection. In this procedure, aninstrument called a resectoscope is placed into the external opening ofthe urethra and an electrosurgical loop is used to carve away sectionsof the prostate gland from within the prostatic urethra under endoscopicvision.

The technique of transurethral resection offers many benefits to thepatient as compared to open prostatectomy. Using this technique, thetrained urologist can remove the hypertrophied prostate with lesspatient discomfort, a shorter hospital stay and lower rates of mortalityand morbidity. Over 333,000 patients underwent this procedure in theUnited States in 1985, with an average hospital stay of six days.Notwithstanding the significant improvement in patient care resultingfrom the widespread application of transurethral resection, thereremains a need for a less invasive method of treating the symptoms ofprostate disease.

One of the earliest methods of relieving acute urinary retention, asymptom associated with prostate disease, was the placement of acatheter through the external urethral opening into the bladder, therebyallowing the outflow of urine from the bladder by way of the catheterlumen. These urinary catheters typically employ a balloon at the tipwhich, when inflated, prevents the expulsion of the catheter from thebody. However, due to problems of infection, interference with sexualactivity, and maintenance involved with such catheters, they aregenerally unacceptable for long term treatment of micturition problems.

U.S. Pat. No. 4,432,757 to Davis, Jr. teaches the use of an indwellingurethral catheter assembly, having a Foley-type balloon disposed nearthe distal end thereof and a substantially non-compliant balloon leadshaft proximate to the Foley-type balloon. The device is adapted to beinserted through the urethra up into the bladder. The Foley-type balloonand the balloon lead shaft are then inflated, although the balloon leadshaft retains relatively non-compliant and therefore does not expandappreciably. Gentle traction is then applied to a catheter sleeve headto sever the sleeve from the remainder of the catheter, leaving theballoon lead shaft in position within the urethra.

Another method of treating hypertrophy of the prostate gland without theneed for surgery has been to inject medications into the prostate glandby means of a catheter. Such a device is disclosed in U.S. Pat. No.550,238 to Allen, wherein two balloons are disposed along two sectionsof a catheter, and inflated to isolate an area within the urethra priorto the injection of the medication. However, these injections arefrequently ineffective as the prostate gland exhibits only a limitedability to absorb the injected antibiotics, and proper positioning andretaining of the catheter with respect to the affected area is extremelydifficult.

A substantial improvement in an apparatus and corresponding method oftreatment for obstructive prostatic hypertrophy is disclosed in Klein,U.S. Pat. No. 4,660,560. In Klein's method, a calibrating catheter isused to measure the distance between the neck of the bladder and thebottom of the prostate gland. A dilation catheter, having an annularballoon with a length equivalent to the measured length, and aFoley-type balloon at the distal end thereof is then inserted into theurethra until the Foley-type balloon is within the bladder. The Foleyballoon is then inflated in the bladder and is used to position thedilation balloon in the prostrate. The latter balloon is then inflated,to force the prostate away-from the urethral lumen. Use of the Kleincatheter can effectively eliminate uncertainty regarding positioning ofthe upper (distal) end of the dilation balloon, thereby significantlyfacilitating the treatment of prostatic hypertrophy.

In practicing the Klein method, after the calibration catheter is usedto measure the length of the affected prostate, it is withdrawn from theurethra, and the dilation catheter is then inserted. Proper insertion ofthe dilation catheter is crucial, as stretching of the external urethralsphincter muscle, which lies just below the prostate, could causeincontinence. Although some means of visualizing placement of theproximal end of the dilation balloon is therefore desirable, thecatheter is too large to fit through a conventional cystoscope sheath.Moreover, bleeding, which is common during such a procedure, notinfrequently obscures the field of view of a cystoscope lens, making ituseless.

Accordingly, in practicing the method of the Klein patent, there is aneed for a method and apparatus to permit effective and sure positioningof the proximal end of the dilation balloon with respect to the externalurethral sphincter. There is a particular need to permit visualizationof the balloon placement in vivo during the course of the surgicalprocedure.

SUMMARY OF THE INVENTION

Briefly, the present invention provides a dilation catheter and sheathof novel design for use as a non-surgical alternative to the treatmentof the symptoms of obstructive prostatism.

In accordance with one aspect of the present invention, there isprovided an intraurethral dilation device for relieving the symptoms ofobstructive prostatism which is adapted for easy insertion into theurethra for pressure dilation of the prostate, so as to force theprostate away from the urethral lumen and thereby eliminate theobstruction. The dilation device is further provided in one embodimentwith an introduction sheath, suitable for housing a cystoscope lens orother locating means, and a dilation catheter. Preferably, the dilationcatheter is provided with an expandible locating balloon, disposed nearthe distal tip of the catheter which, when inflated within the bladder,will provide an anchor with the bladder neck. At least one dilationballoon is preferably provided on the catheter, proximate the locatingballoon which, when inflated, conforms to a preselected configuration,so as to radially outwardly dilate the obstruction away from theurethral lumen.

In accordance with a further embodiment of the present invention, thereis provided an intraluminal dilation apparatus having non-radiologicalmeans thereon for locating the position of a dilation means within abody lumen, with respect to an anatomical landmark. The apparatuscomprises an elongate catheter, having a means for dilation of the bodylumen carried thereon. Preferably, the dilation means is an inflatableballoon, and, in an alternative embodiment, the dilation means comprisestwo or more axially adjacent, independently controlled dilationballoons. The apparatus further comprises a locating means associatedwith the dilation catheter for locating the dilation means with respectto the anatomical landmark. Preferred locating means include a standardcystoscope, an ultrasound transducer, a muscle contractility detector oran electromylogram pick-up.

There is additionally provided a method of treating the systems ofobstructive prostatism by dilation of the prostatic urethra, comprisingthe steps of inserting a dilation means into the urethra, the dilationmeans having a non-radiological locating means for positioning thedilation means relative to an anatomical landmark. The location of thedilation means within the urethra is adjusted with respect to theanatomical landmark using the non-radiological locating means, and thedilation means is thereafter expanded so as to radially outwardly dilatethe prostatic urethra.

Further objects, features and other advantages of the present inventionwill become apparent from the ensuing detailed description, consideredtogether with the appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a dilation catheter and sheath assemblyin accordance with one embodiment of the present invention;

FIG. 2 is a partial assembly view of the clipping mechanism;

FIG. 3 is a perspective view of a septum, showing an inwardly extendingboot sleeve in cut away;

FIG. 3a is a perspective view of a second type of septum, having bothboot sleeves projecting outwardly;

FIG. 4 is an end view of the sheath, showing the unique ellipsoid shapeof the inner walls thereof;

FIG. 5 is a perspective view of the tip of the sheath, as being deformedby a once-inflated dilation balloon, so as to guide the balloon into thesheath before removal from the urethral lumen;

FIG. 6 is a side view of the tip of an obturator;

FIG. 7 is a side view of the sheath, having an obturator disposedtherein, as ready for insertion into the urethra;

FIG. 8 is a cross-sectional view, taken along line 8--8 of FIG. 7,showing in more detail the obturator removably disposed therein;

FIG. 9 is a cross-sectional view, illustrating a plastic manifolddisposed at the proximal end of the dilation catheter during the moldingprocess;

FIG. 10 is a cross-sectional view, taken along line 10--10 of FIG. 11,showing the lumen arrangement within the catheter shaft;

FIG. 11 is a side view of a dilation catheter, having a stylet removablyinserted therein;

FIG. 12 is a cross-sectional view, taken along line 12--12 of FIG. 11,showing the overlap of the shoulder of the locating balloon with theshoulder of the dilation balloon;

FIG. 13 is a side view of a dilation balloon, in an inflated state,exhibiting a squared-off configuration at one end, and a taperedconfiguration at the opposite end thereof, in accordance with oneembodiment of the present invention;

FIG. 14 is a side view of a dilation balloon, having both ends in atapered configuration, in accordance with an alternative embodiment ofthe present invention;

FIG. 15 is a side view of a calibration catheter, showing a partial cutaway view of an inflation aperture for the expandable balloon;

FIG. 16 is a magnified view of the marking disposed near the proximalend of the dilation balloon showing clearance of the external sphinctermuscle; and

FIG. 17 is a cross-sectional view of the urethral dilation catheter ofthe present invention operatively inserted within the male urinarytract.

FIG. 18 is an elevational view of a dilation catheter having atransducer thereon for locating an anatomical landmark.

FIG. 19 is a perspective view of a dilation catheter having an integralobturator thereon.

FIG. 20 is a perspective view of a dilation apparatus having a lockingbridge.

FIG. 21 is an enlarged perspective view of a locking bridge.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings in detail, wherein like reference numeralsdesignate like elements throughout the several views thereof, there isshown generally at 10 in FIG. 1, a dilation catheter and sheath assemblyembodying the present invention in a preferred form. The sheath 12 isadvantageously a substantially rigid, axially elongate hollow shaftthroughout most of its length, but having a flexible distal tip 14. Thesheath 12 exhibits an inner surface 16 which is substantially ellipsoidin cross-section, and is adapted to receive and guide an axiallyelongate catheter 18 and an endoscope 20 longitudinally therethrough.Advantageously, the particular endoscope used is known as a cystoscope.Alternatively, a variety of other means for locating anatomicallandmarks within the body lumen may be used, as discussed infra.

In one embodiment of the invention, a cylindrical housing 22, disposednear the base of the sheath, exhibits a pair of grooves 24, formed upontwo flattened surfaces 26 of the cylindrical housing 22, on oppositesides thereof. An end view of the cylindrical housing 22, as shown inFIG. 4, illustrates the ellipsoid shape of the inner walls 15 of thesheath 12, and the flattened side surfaces 26 thereof. A U-shaped clip28 is integrally connected to the top of an inflation device 30 and isadapted to removably receive and retain the cylindrical housing 22 so asto enable the device 10 to be operated by one person, without the needfor assistance. The removable attachment of the sheath 12 to theU-shaped clip 28 is illustrated in FIG. 2. A C-shaped clip 32 may alsobe provided on the body of the inflation device 30, to removably receiveand retain the catheter 18 therein and provide additional support forthe proximal end of the device, thus controlling the catheter so it doesnot interfere with the eyepiece of the endoscope.

Situated on the underside 36 of the cylindrical housing 22 is a drainageport 38, having a cock valve 40 secured therein. The cock valve 40 isadapted to allow back-flowing fluids to escape the sheath 12 whenpositioned in the "on" position, and to prohibit the release of suchfluids when in the "off" position.

The cylindrical housing 22 includes a hub portion 42, disposed at theproximal end thereof. A rubberized septum 44, preferably formed from asilicon rubber compound, is detachably placed onto the hub 42 of thecylindrical housing 22 so as to provide a seal therefor. As best seen inFIGS. 3 and 3a, the septum 44 is a circular cap 46, having a pair ofboot sleeves 48, 50 integrally connected to the proximal end of the cap46. In one embodiment, the septum 44 exhibits an outwardly extendingboot sleeve 48 an inwardly extending boot sleeve 50. The boot sleeves48, 50 are adapted to receive the cystoscope lens 20 and the dilationcatheter 18, and provide the septum 44 with elasticity at the point ofcontact therebetween. Without the presence of such sleeves, therubberized septum 44 would itself deform if a force were applied toeither the catheter 18 or cystoscope lens 20, thereby detracting fromthe septum's sealing ability. Further, the boot sleeves 48, 50 areadapted to readily adjust to and grip the outer diameter of the catheter18 and lens 20 to yield a good seal therebetween. In an alternativeembodiment, as shown in FIG. 3a, both of the boot sleeves 52, 54 extendoutwardly from the septum cap 44. This embodiment is possible only whenthere exists sufficient room on the outside of the septum, such that asharing of a common wall between the two sleeves is not necessitated.

As best seen in FIG. 11, the dilation catheter 18 of the presentinvention comprises an axially elongate catheter shaft 56, having atapered guiding end 58, and a plurality of parallel conduits disposedtherein. Situated near the guiding end 58 of the catheter shaft 56 is alocating balloon 60. The locating balloon 60 is a small latex Foley-typeballoon, adapted for inflation by a source of pressurized fluid.Adjacent the locating balloon 60 is a larger dilation balloon 62, havinga proximal shoulder 64 and a distal shoulder 66.

A feature of this invention is that the distal shoulder 66 of thedilation balloon 62 is overlapped by a portion of the locating balloon60, such that, when the balloons are expanded, a minimal valley is leftbetween the two balloons. Both of the balloons 60, 62 are bonded to theouter perimeter of the catheter shaft 56 by suitable adhesive or thermalprocess. In a similar manner, more than one axially adjacent dilationballoons can be provided on the dilation catheter, each provided with aunique inflation lumen extending through the catheter to a selectivelycontrollable pressure source. The use of two or three or more dilationballoons permits control over the effective length of the dilationregion of the catheter, as will be understood by one of skill in theart.

While the overlap of the locating balloon 60 onto the shoulder 66 of thedilation balloon 62 increases the area of dilation by minimizing thedistance between the locating balloon 60 and the dilation balloon 62,suboptimal dilation of the affected prostatic urethra 68 still existsdue to the tapered nature of expandable balloons, commonly used indilation processes. To achieve optimal dilation near the ends 70, 72 ofthe affected prostatic urethra 68, the dilation balloon 62 can be moldedwith a steep, squared off end 74, as illustrated in FIG. 13. Dependingon the nature of the affected area of the prostatic urethra 68, it maybe desirable to enable urethral dilation very close to the bladder neck72 or the external sphincter muscle 70. Accordingly, either end of thedilation balloon 62, neither end, or both ends may be provided with asubstantially vertical configuration as illustrated in FIGS. 13, 14 and17.

A material which is well adapted to construction of the dilation balloon62 of the present invention is polyethylene terephthalate (PET), such asKODAK's 9921. Preferably, the balloon 62 is extruded in a straight pipeconfiguration and then stretched and blown under high temperature andpressure to yield the desired shape 74. This type of technique iscommonly applied in the making of angioplasty balloons. It should benoted that the PET material used to construct the dilation balloonexhibits superior tensile strength characteristics to that of materialsused in manufacturing other types of dilation balloons, for exampleolder angioplasty balloons. The PET material used to construct thedilation balloon of the present invention has a tensile strength ofbetween 20,000 to 50,000 psi, and is rated to withstand at least 3atmospheres of pressure, and as much as 5 atm.

If a rubberized latex material were used to fabricate the dilationballoon of the present invention, the walls of the balloon wouldnecessarily be much thicker in order to withstand the exceedingly highpressures required for adequate dilation of the affected prostaticurethra. Thus, the PET material, by virtue of its superior strength,allows a thinner balloon to be utilized. The thinness of the balloonthus formed, makes possible a dilation balloon 62 which, in anuninflated state, conforms to the external walls of the catheter shaft56, thereby providing a dilation catheter 18 having substantially thesame size and shape as the unstretched lumen. However, the increasedstrength of the material also dictates a balloon which is somewhat stiffand substantially less pliable than a latex balloon.

Consequently, when negative pressure is applied to collapse the dilationballoon 62 made of the PET material, sharp ridges may form on theexterior surface thereof. Advantageously, the distal tip 14 of theintroduction sheath 12 is formed of a flexible material, which readilydeforms to the gross contours of the deflated dilation balloon 62, so asto coerce the balloon 62 into the introduction sheath 12 prior to thewithdrawal of the catheter 18 from the urethra. Preferably, the tip 14is formed from a substantially malleable Poly Vinyl Chloride (PVC)compound, which is RF welded to rigid shaft portion 12 of the sheath.

To ensure that the catheter 18 is fully within the introduction sheath12 prior to the withdrawal thereof, visual indicia, such as the marking78 on the exterior shaft 56 of the catheter 18 is provided. As thecatheter shaft 56 and deflated dilation balloon 62 are graduallywithdrawn from the urethra, the indicia 78 will be advanced out of thesheath 12. When the designated indicia 78 becomes visible, the catheter18 is fully retracted within the sheath 12, and the device 10 may bewithdrawn, without causing undue trauma to the urethral lumen.

As best seen in cross-section in FIG. 10, the catheter shaft 56 houses apair of circular inflation conduits 80, 82 and an irrigation conduit 84.The inflation conduit 80 having an aperture 86 underlying the locatingballoon 60 exhibits a tubular passageway which permits pressurized fluidto be transmitted into the chamber enclosed by the locating balloon 60 ,so as to selectively inflate the balloon 60 to a suitable level.Likewise, the inflation conduit 82 having a pair of inflation apertures90, 92 underlying the dilation balloon 62 allows pressurized fluid toselectively fill the balloon 62 to a desired level.

To facilitate inflation of the locating balloon 60, a simple fluid valve94 may be connected to the proximal end of the conduit 80. This valve 94is integrally connected to the inflation conduit 80 and may be easilymanipulated to allow quick sealing of the conduit 80 and maintain thepressurized fluid within the balloon chamber 60 and the conduit 80. Thelocating balloon 60 may be pressurized by inserting a hypodermic syringe(not shown) into the valve 94, with the valve 94 in its open condition.By forcing fluid into the conduit 80, the locating balloon 60, at thedistal end of the inflation conduit will be inflated. The valve 94 maythen be closed, and the hypodermic syringe removed, leaving the locatingballoon 60 in an inflated state.

Since inflation of the dilation balloon 62 is more critical, the sourceof pressurized fluid 98 used to inflate the dilation balloon 62 isconnected to a pressure gauge 100. Preferably, the inflation device 98includes a syringe barrel 102 having a threaded rod and ratchetmechanism 104 which replaces the conventional plunger. Thisconfiguration allows fine tuning of the pressure amassed within thedilation balloon 62 by screw turning the threaded rod 104. It has beendetermined that an intraballoon pressure of approximately 3 atm., or 45p.s.i.g. is sufficient to force the prostate away from the urethrallumen to relieve the obstruction and reestablish normal micturition.

As a further alternative, the dilation catheter of the present inventioncan be configured to carry an expandable implantable stent over thedilation region thereof. This embodiment of the present invention wouldpermit both expansion of the urethra and leaving behind of an expandedintraluminal support to ensure long-term patency of the urethra. The useof such implantable stents is disclosed in detail in U.S. Pat. No.4,762,128 issued to Robert F. Rosenbluth on Aug. 9, 1988, the disclosureof which is hereby incorporated by reference in the present case.

The catheter comprises a radially expandable region near the distal endthereof which, in its unexpanded state, has an outer diameter that ispreferably slightly smaller than the outer diameter of the adjacentregion of the catheter. Thus, the collapsed expandable region forms thebottom of an annular depression about the catheter.

The stent is removably, coaxially disposed about the expandable regionof the catheter and within the annular depression formed therearound,and is controllably radially outwardly expandable in response topressure from the expandable region of the catheter. When the stent iscoaxially disposed about the expandable region of the catheter, and inan unexpanded state, the outer diameter of the unexpanded stent isapproximately the same as or less than the outer diameter of theadjacent region of the catheter. Preferably, the distal end of thecatheter comprises a flexible, resilient material in a shape tofacilitate insertion into and negotiation of a collapsed lumen withminimal trauma to the lining thereof. Alternatively, for use with anintroduction sheath, the stent may extend radially outwardly of theadjacent catheter shaft in the unexpanded state.

The radially outwardly expandable tubular stent for restoring patency toa collapsed portion of the urethral lumen comprises a material that iscompatible with the urethral environment, and is capable of remaining inits expanded state following removal of the expansion catheter describedabove, thereby holding open the lumen of the urethra against arestricting pressure, such as that exerted by a hypertrophied prostategland. The cross section of the expanded stent may be circular, or mayalso be a non-circular configuration which more closely corresponds tothe shape of the normal lumen within the urethra. One embodiment of thestent in its expanded state comprises a substantially uniformcross-sectional area throughout its axial length. In another embodiment,the stent comprises a smaller cross-sectional area at its axial endsthan in the central region thereof. In addition, the axial end regionsof the stent may comprise a flexible material, or may taper in a radialinward direction thereby easing the transition from the lumen of thestent to the lumen of the urethra.

Referring to FIGS. 11 and 16, near the proximal end of the dilationballoon 62, and encircling the proximal shoulder 64 thereof, is a visualindicator, such as a heavy black line 106 for use with the cystoscopeembodiment of the present invention. The visual indicator can also be aradial enlargement on the catheter, such as a radially outwardlyextending annular ridge. Prior to inflating the dilation balloon 62,care should be taken to ensure that the visual indicator, such as theblack line 106 does not extend onto any portion of the external urethralsphincter muscle 108. This is vitally important as accidental dilationof the sphincter 108 may cause the patient to lose voluntary controlover micturition, especially if the sphincter experiences plasticdeformation, i.e., the inability to return to its original shape.

An important feature of this invention is the provision of an irrigationsystem. As described below, the system provides the dual features ofboth flushing blood away from the lens of the cystoscope to aid in theviewing of the external sphincter muscle and the black line 106 on theshoulder 64 of the dilation balloon 62 and inhibiting coagulation ofblood within the urethra. This flushing system includes a plurality ofirrigation ports 110 disposed along the exterior shaft 56 of thecatheter 18, proximate to the line 106 are provided. The irrigationports 110 are adapted to continuously flush fluid, for example, saline,from the irrigation conduit 84, which extends through the center of thecatheter shaft 56. The irrigation conduit 84 is provided with a couplingdevice 112 at the proximal end thereof, adapted to receive a source offlushing fluid, which, for example, can be a hanging container of saline(not shown), having a length of flexible tubing extending therefrom, forconnection to the coupling device 112. The source of fluid is elevatedand allowed to flow by gravity through the irrigation conduit 84 and outthe irrigation ports 110, so as to flush blood away from the lens 20 andallow the urologist an unobstructed view of the external sphinctermuscle 108 and the line 106 encircling the proximal shoulder 64 of thedilation balloon 62.

In addition to permitting an unobstructed view of the proximal shoulder64 of the balloon 62, the flushing of blood inhibits coagulation, andtherefore substantially eliminates clotting within the urethral lumen.Backflowing flushing fluid and blood is drained from the urethra throughintroduction sheath 12 by gravity flow. A drainage reservoir (not shown)is connected to the cock valve 40 which, when in its open position,allows the backflowing fluids to drain, by gravity flow, into thereservoir and subsequently disposed of. Alternatively, the flushingfluid can be supplied through the sheath 12 to flush blood away from thecystoscope lens 20. In this embodiment, the irrigation ports 110 of theirrigation conduit 84 function as influent ports to drain the flushingfluid and blood out of the urethra.

Located at the proximal end of the catheter shaft 56, and integrallyconnected thereto, is a Y-shaped plastic manifold 118. The manifold 118is adapted to define and separate the trio of conduits 80, 82, 84disposed within the body of the catheter shaft 56. Preferably, themanifold 118 is preformed in the Y-shaped configuration and is adaptedto connect to the catheter shaft 56 and trio of conduits at the proximalend thereof. The catheter shaft 56 should be bent and cut to expose theinflation conduits 80, 82 respectively. The irrigation conduit 84 neednot be exposed in this manner, as the manifold 118 includes asubstantially straight portion in which the proximal end of theirrigation conduit 84 will reside. As shown in FIG. 9, during themolding process flexible core pins 122, 124 are inserted into theexposed inflation conduits 80, 82 to respectively maintain the openingsinto the inflation conduits and provide support therefor during themolding process. In a similar manner, a straight core pin 126 isinserted into the irrigation conduit 84, and the catheter 18 is set intothe preformed plastic manifold 118. Plastic is then injected into themanifold 118 to form a tight seal, and the core pins 122, 124, 126 areremoved after the plastic has hardened.

A variety of means other than cystoscope 20, discussed above, can beprovided on the dilation catheter or the sheath for positioning thedilation means relative to an anatomical structure. Typically, theanatomical structures most convenient for positioning the dilation meansare the bladder neck and the external sphincter.

For example, referring to FIG. 18, a transducer 160 such as anultrasound transducer may be molded integrally with or bonded to adilation catheter 162 having a dilation means 164 thereon. Ultrasoundtransducer 160 will permit visualization of anatomical structures withinthe body lumen in accordance with well known instrumentation andtechniques. The ultrasound transducer 160 may be positioned either onthe distal end 166 of the dilation means 164 (not illustrated), toenable visualization of the bladder neck, or on the proximal end 168 ofthe dilation means 164, to enable visualization of the externalsphincter. The ultrasound transducer may be oriented on the dilationcatheter such that the scanned image extends either in a radial planeperpendicular to the axis of the catheter, or in a plane parallel to theaxis of the catheter. Alternatively, in an embodiment of the presentinvention such as that illustrated in FIG. 1, having an introductionsheath 12, an ultrasound transducer 160 can be located at a convenientposition on the introduction sheath 12, such as at or near the flexibletip 14.

Electrical wiring from the ultrasound transducer to a conventionalexternal ultrasound monitor may be conveniently run through a lumen inthe dilation catheter provided for that purpose, or can be integrallymolded within the catheter body. The external display terminal willprovide a visual field which enables the clinician to identify thesphincter, the prostate, the bladder or other anatomical features withinthe urethra. In accordance with the method of the present invention, thenon-radiological locating means can also comprise an external ultrasoundtransducer for observing positioning of the dilation catheter.

Certain anatomical structures within or surrounding the urethra can alsobe located by means of a detector located on the dilation catheter asdiscussed in connection with transducer 160, or on an introductionsheath for detecting the muscle contractility or compressive forces inthe urethral wall. Thus, muscle contractility, or the presence of musclein the urethral wall, can be detected by placing a strain gauge, orforce or pressure transducer on the catheter shaft in any of thelocations discussed in connection with transducer 160. Such a transducerwould detect the presence of a radially inwardly directed force, such aswould be found at the bladder neck and external sphincter, and wouldthereby allow positioning of the catheter with the transducer in theregion of such radially inwardly directed force. The detector canalternatively be located beneath the deflated balloon for other dilationmeans. The output from the muscle contractility detector is transmittedby way of wiring extending axially through the catheter or introductionsheath to an external processing device such as are well known in theart.

The contractility detector may be conveniently bonded or molded into thedilation catheter at a position relative to the dilation means suchthat, when the detector is axially aligned with the external sphincter,the bladder neck, or any other anatomical landmark capable of generatinga signal, the dilation means will be disposed within the prostaticurethra. This may be accomplished by providing the muscle contractilitydetector at a position either distally of, or proximally to, thedilation means as discussed in connection with the location of anultrasound transducer. Piezoelectric transducers, or other pressuretransducers, can be readily adapted for use on a dilation cathetersystem, as will be appreciated by one of skill in the art. Similarly, astandard EMG pickup for producing an electromylogram can be mounted onthe dilation catheter or sheath, and coupled to conventional signalprocessing equipment. As will be apparent to one of skill in the art,any of the foregoing transducers can be used on a dilation catheter withor without a distal locating balloon such as balloon 60 in FIG. 17.

Optimally, the outer peripheral surface of the transducer will notextent significantly beyond the outer surface of the catheter and, mostpreferably, the surface of the transducer will be flush-mounted withrespect to the immediately surrounding area of the dilation catheter. Aswill be understood by one of skill in the art, it may be desirable toprovide an outer coating or layer of a biocompatible material over thetransducer to prevent contact between the transducer and urethralintima, and to minimize any rough or uneven edges.

In accordance with a further embodiment of the present invention, asource of pulsatile pressure (not illustrated) is provided for inflatingthe dilation balloon. Pumps capable of generating a variable frequencypulsatile pressure are well known in the art, and can readily beconstructed by a cam-driven piston pump, as will be appreciated by oneof skill in the art. By introducing and withdrawing fluid through thedilation port of the catheter, the balloon can be made to pulse at adesired frequency. Preferably, a pulsatile pressure source is connectedto the dilation balloon which is capable of vibration at about thenatural body frequency of approximately 8 Hz. High frequency pulsationof the balloon can be accomplished by providing an acoustic transduceron the dilation catheter, such as within the dilation balloon, anddriven by an external variable frequency source of acoustic vibration.However, lower or higher frequencies such as from 1/60 Hz to as high as5000 Hz may also facilitate reduction of the symptoms of obstructiveprosthetism.

In accordance with a further embodiment of the dilation catheter of thepresent invention, illustrated in FIG. 19, there is provided a dilationcatheter 170, having a dilation balloon 172, or other dilation meansthereon, which is provided at its distal end 174 with an integrallymolded, or otherwise secured, obturator 176 for facilitatingintroduction of the dilation catheter within the urethra. The obturator176 may be molded or formed from any of a variety of materials which aresubstantially biologically inert in the urethral environment, and whichfacilitate secure bonding to the material of the dilation catheter shaft170 so that the obturator 176 will not become detached from the shaft inuse. For example, a polyvinylchloride (PVC) obturator may be securelybonded to a PVC catheter shaft.

The dilation catheter 170 having an integral obturator 176 thereon maybe used either alone or in combination with an introduction sheath 178,and preferably is used together with an introduction sheath 178. Forthis purpose, the proximal end 180 of the integral obturator 176 istapered slightly as illustrated in FIG. 19, so that is may be snuglyfitted within the distal end of the introduction sheath 178.

An integral obturator 176 can also be configured like the obturator 148in FIGS. 7 and 8, with a more gradual taper to cooperate with flexibletip 14 of sheath 12. In addition, as with the flexible distal tip 14illustrated in FIG. 5, sheath 178 can be further provided with aflexible region 179 for receiving proximal end 180 when the catheter isin the retracted position.

Following introduction of the sheath 178 in accordance with the presentembodiment of the invention, the dilation catheter 170 and integralobturator 176 may be extended distally relative to sheath 178 to exposethe dilation means 172. The dilation means is then positioned inaccordance with any of the positioning techniques described herein, anddilation is accomplished. Following dilation, the dilation means isreduced in external diameter, and the dilation catheter is retractedaxially into the sheath so that the proximal end 180 of the obturator176 fits snugly within the distal end of the sheath 178.

Referring to FIGS. 20 and 21, there is illustrated a locking bridge 186for facilitating control over the various components of the dilationassembly, according to one embodiment of the present invention. Dilationcatheter 182 is illustrated as extending through a dilation assemblyhousing 184 in a manner similar to that discussed in connection withFIG. 1. Dilation catheter 182 ,is additionally illustrated as extendingthrough a tubular channel 183 contained in locking bridge 186, enablinga variety of securing functions as will be discussed.

A first locking means 188, such as a thumb screw 190, is provided on thelocking bridge 186, for securing the locking bridge 186 with respect tothe dilation catheter 182. Although illustrated as a thumb screw 190,the first securing means 188 may comprise any of a variety of means wellknown to one of skill in the art which may be adapted for securinglocking bridge 186 against axial movement along dilation catheter 182.

Locking bridge 186 is further provided with a second tubular channel 192for receiving a standard cystoscope or other locating meanstherethrough. Channel 192 is provided with a second securing means 194for securing the endoscope with respect to locking bridge 186. Asdiscussed in connection with first securing means 188, the secondsecuring means 194 can be any of a variety of means known in the art forsecuring a tubular member against axial motion through the lockingbridge 186.

For example, referring to FIG. 21, the second securing means 194 cancomprise a rotatable sleeve 196 having a lever 198 thereon to facilitaterotation. The sleeve 196 is threadably engaged with the body of lockingbridge 186, and rotation of sleeve 196 provides a compressive retentionforce on an elongate body extending through channel 192, such as bycompression of an annular ring of elastomeric material, or radial inwardmovement of a multiple jaw chuck, as are well known in the art. Lockingbridge 186 is preferably additionally provided with a further securingmeans (not illustrated) for securing locking bridge 186 to the dilationassembly housing 184. This further securing means may comprise any of avariety of securing means, as will be appreciated by one of skill in theart.

The foregoing structures enable the clinician to fix the axial positionof the dilating means in relation to the sheath, to fix the position ofthe locating means with respect to the sheath and to alternatively fixthe position of the locating means with respect to the dilating means.

Method of Using the Dilation Catheter

Prior to dilating the obstructed urethral lumen, the length of theaffected prostatic urethra 68 should be measured. This may beaccomplished by the use of a calibration catheter 128, as illustrated inFIG. 15. The calibration catheter 128 is an axially elongate shaft 130,having an expandable balloon 132 located near the distal end 134thereof, and an inflation conduit (not shown) which extendssubstantially the entire length of the shaft 130. The expandable balloon132 is adapted to be inflated through an inflation aperture 136,extending from the inflation conduit by a source of pressurized fluid(not shown). A plurality of graduated markings 138 extend along theexterior shaft 130 of the catheter 128, commencing near the proximal end140 of the expandable balloon 132, and are adapted to be read from thedistal end 134 of the catheter 128 to the proximal end 142.

The calibration catheter 128 is adapted to be received into the sheathof a standard cystoscope, and the cystoscope inserted into the urethrathrough the penile meatus. Once the distal end 134 and expandableballoon 132 of the calibration catheter 128 enters the bladder 144, theexpandable balloon 132 may be inflated, and the catheter 128 slowlywithdrawn from the urethra until the balloon 132 becomes lodged withinthe bladder neck 72. Graduated markings 138, inscribed on the exteriorshaft 130 of the catheter 128 can be used to measure the distancebetween the bladder neck 72 and the lower end 70 of the affectedprostatic urethra 68. Once such a measurement has been determined, theexpandable balloon 138 may be deflated, and the catheter 128 withdrawn.

An introduction sheath 12, as illustrated in FIGS. 7 and 8 is thenreadied for insertion through the external urethral opening. Anobturator 146, as shown in FIGS. 6, 7 and 8, having a smooth, taperedend 148 with no sharp edges is inserted into the sheath 12, and securedto the hub 42 of the cylindrical housing 22 by chamfered clips 150. Theflexible tip 14 of the sheath 12 tapers inwardly, so as to grip theextending portion of the obturator 146 and provide a fairly smoothsurface continuation of the introduction sheath. This mild transitionbetween the obturator 146 and sheath 12 is instrumental in reducingdamage and trauma to the tender urethral lumen. Once the sheath 12 hasbeen fully inserted within the urethral lumen, the chamfered clips 150may be released, and the obturator 146 withdrawn.

A catheter shaft 56, having a dilation balloon 62 with a lengthapproximately equivalent to that measured by the calibration catheter128, is then inserted through one 48 of two boot sleeves of the septum44, until at least that portion of the catheter shaft 56 to which theexpandible balloons 60, 62 are attached extends therethrough. The septum44 is then friction fit onto the hub 42 of the cylindrical housing 22such that the catheter 18 is in alignment with the larger diameterellipsoid section 152 of the sheath 12. The cystoscope lens 20 is theninserted into the other boot sleeve 50, and is then urged through thesheath 12 and into the urethra after placement of the catheter 18.

To provide support for the catheter 18, an elongate stylet 154 may beinserted into the irrigation conduit 84, as illustrated in FIG. 11. Thestylet 154 facilitates the ease with which the catheter 18 may beinserted into the urethra, and may remain within the irrigation conduit84 until the locating balloon 60 is disposed within the bladder 144, atwhich time the stylet 154 should be removed. Once the locating balloon60 is within the bladder 144, the inflation conduit 80 may be coupled toa source of pressurized fluid so as to inflate the locating balloon 60.The catheter 18 is then gradually withdrawn from the bladder 144 untilthe balloon 60 is lodged within the bladder neck 72. When the locatingballoon 60 is properly positioned within the neck 72 of the bladder 144,a seal is formed therebetween which prohibits fluids accumulating withinthe bladder 144 from travelling down the urethra and also prohibitsfluids from flowing into and filling up the bladder from the urethra.

Once the catheter 18 has been properly situated with respect to theupper end 72 of the affected prostatic urethra 68, the irrigationconduit 84 may be connected to a source of flushing fluid. The flushingfluid is gravity fed through the irrigation conduit 84 and out theirrigation ports 110, so as to wash existent blood away from thecystoscope lens 20 and provide the urologist with an unobstructed viewof the proximal shoulder 64 of the dilation balloon 62, and adjacentorgans. Looking through the cystoscope, the urologist can manipulate thecatheter 18 to confirm that the dilation balloon 62 is clear of theexternal urethral sphincter muscle 108, so as to ensure that thesphincter 108 will not inadvertently be dilated.

Upon properly positioning the dilation balloon 62 with respect to boththe bladder neck 72 and the sphincter 108, the inflation conduit 82 forthe dilation balloon 62 may be connected to a source of pressurizedfluid 98. As described above, the inflation source 98 should enable aaccurate, progressive dilation under constant control of the pressurebeing applied within the dilation balloon 62. The device remains withinthe affected prostatic urethra 68, until sufficient pressure dilationhas been achieved. Subsequent to attaining adequate pressure dilation ofthe prostatic urethra, and eliminating the urinary outflow obstruction,the balloons 60, 62 may be deflated, releasing the pressurized fluidtherefrom.

As the dilation balloon 62 is deflated, sharp ridges may form on theouter surface thereof, due to the stiffness of the material from whichit was formed. As shown in FIG. 5, the flexible tip 14 of theintroduction sheath 12 readily deforms and flares, so as to coerce thedilation balloon 62 back into the sheath 12. When the marking 78,indicative of the time at which the dilation balloon 62 is completelywithin the sheath 12 becomes visible, the device may be withdrawn fromthe urethra.

In view of the medical treatment to be administered in using the deviceof the present invention, it is necessary that the device be asepticallyclean. Accordingly, the dilation catheter and sheath can be cleansed andsterilized readily and easily either prior to use thereof, or packagedin this condition, available for immediate use. Further, both thecatheter and sheath may be discarded after use, negating the need forrecleaning and resterilization.

It will be appreciated that certain structural variations may suggestthemselves to those skilled in the art. The foregoing detaileddescription is to be clearly understood as given by way of illustration,the spirit and scope of this invention being limited solely by theappended claims.

What is claimed is:
 1. A method of treating the symptoms of a flowobstruction of a urethra, comprising the steps of:inserting aninstrument into the urethra, said instrument having a support structureremovably, coaxially disposed about a radially expandable region of saidinstrument, said instrument also having a visual indicator thereonproximal to said support structure for positioning the support structurerelative to the obstruction while avoiding an external urethralsphincter; positioning the support structure within the obstruction bypositioning the visual indicator within the urethra at the lower end ofthe affected prostatic urethra under direct vision without use ofx-rays; ensuring that the visual indicator does not extend onto anyportion of the external urethral sphincter in order to avoid dilation ofthe external urethral sphincter; and expanding the support structure soas to radially outwardly dilate the urethra, whereby the obstruction isalso dilated.
 2. The method of claim 1, wherein said instrument is aballoon catheter having a balloon thereon for radially outwardlydilating the support structure.
 3. The method of claim 1, wherein saidsupport structure is axially elongate.
 4. The method of claim 1, whereinthe instrument is removed, leaving the support structure within thedilated portion of the urethra.
 5. The method of claim 1, wherein thevisual indicator comprises a radial enlargement on said instrument. 6.The method of claim 5, wherein the radial enlargement comprises aradially outwardly extending annular ridge on said instrument.
 7. Themethod of claim 1, wherein the visual indicator comprises a line on saidinstrument.
 8. The method of claim 1, wherein the support structure is astent.
 9. The method of claim 8, wherein the radially expandable region,in its unexpanded state, has an outer diameter that is slightly smallerthan the outer diameter of the adjacent region of said instrument,whereby the radially expandable region, in its unexpanded state, formsan annular depression about said instrument.
 10. The method of claim 9,wherein the stent is disposed within the annular depression.